Kornimate/medical-research-clean huggingface dataset:
critical illness outcomes study

Conditions: Critical Illness; Intensive Care; Intensive Care Unit

Summary: we will test whether the way that an intensive care unit is organized can influence patient related outcomes such as mortality. we will test whether who works in the icu, and how the icu is managed will affect the care received by patients. the primary study hypothesis is whether the number of clinical protocols present in an intensive care unit is linked to patient mortality

title: do icu structural and procedural factors influence patient related outcomes: the critical illness outcome study (cios) objectives: this is an exploratory ecologic study designed to examine the organizational and structural factors present in adult intensive care units in the united states. a second objective is to determine whether these organizational and structural factors are associated with patient related outcomes. in addition, we intend to examine whether these organizational and structural issues are associated with patient treatments. hypotheses: (ho) a. the number of protocols used in an icu is inversely associated with icu and hospital survival for critically ill patients. b. compliance with disease specific protocols is not independently associated with hospital survival for critically ill patients specific aims 1. to describe the organizational structure of participating intensive care units 2. to determine whether the number of protocols used in an intensive care unit is associated with icu and hospital survival for critically ill patients 3. to determine the frequency with which icu's follow disease specific protocols for patients with sepsis and ali study design 1. prospective ecologic study of 50-60 adult intensive care units and admitted patients 2. icu organizational and structural data will be collected for each participating icu 3. 125-200 adult patients in each intensive care unit will be enrolled. patients within the icu on a varying, specific day each week will be included. demographic and treatment variables will be collected for that day on that patient. outcome data will be collected on icu and hospital discharge.

Eligibility criteria:
inclusion criteria: - hospitalized adult patient in a study icu on the date of data collection. this includes patients who may be in icu despite not having critical illness for reasons such as lack of floor beds. exclusion criteria: - 1. patient enrolled on previous study collection day 2 previous enrollment into other study icu 3. age \< 18 years

Keywords: protocol critical pathway intensive care units
drug use investigation of somatropin for ghd-adults.

Conditions: Dwarfism, Growth Hormone Deficiency

Summary: post marketing drug use investigation of genotropin for ghd-adults.

all the patients whom an investigator prescribes the first somatropin should be registered consecutively until the number of subjects reaches target number.

Eligibility criteria:
inclusion criteria: the patients who were administered somatropin to treat "adult growth hormone deficiency (limited to severe type)". exclusion criteria: patients not administered somatropin.
long term evaluation of human acellular dermal matrix allograft for coverage of the wound after extensive deep burn

Conditions: Burn; Traumatic Implants

Summary: the present study was to retrospectively evaluate the long-term outcomes of the cograft acellular dermal matrix (adm) with autologous thin split-thickness skin for coverage of functional regional wounds in burned patients.

the potential of acellular dermal matrix (adm) had been proved to improve cosmetic and functional outcomes, nevertheless, there had been few reports about the long term results of the morphological, histological and functional changes after placement. the present study was to retrospectively evaluate the long-term outcomes of the cograft acellular dermal matrix (adm) with autologous thin split-thickness skin for coverage of functional regional wounds in burned patients.

Eligibility criteria:
inclusion criteria: * the patient's skin with adm implant exclusion criteria:

Keywords: burns wound repair skin substitutes
efficacy and safety of mc2-25 cream & vehicle in women with vulvar lichen sclerosus (vls)

Conditions: Vulvar Lichen Sclerosus

Summary: the purpose of this study is to explore the efficacy and safety of mc2-25 cream and mc2-25 vehicle in women with vulvar lichen schelosus (vls).

in this study, subjects who fulfil all inclusion and exclusion criteria are enrolled. eligible subjects will be randomized in a 1:1 ratio to mc2-25 cream or mc2-25 vehicle, respectively. the subjects will apply the assigned investigational medicinal product (imp) daily for 12 weeks.

Eligibility criteria:
inclusion criteria: * women, of any race or ethnicity, who are ≥18 years of age at the time of screening. * able to understand the trial and willing to comply with trial requirements. * has provided written informed consent. * clinical diagnosis of vls. * presence of at least one of the following signs of vls: hyperkeratosis and/or sclerosis. * first symptoms of vls noticed by the patient at least 6 months before baseline. * at least four wi-nrs scores available in the diary for calculation of the average wi-nrs at the baseline visit. * at least moderate itch defined as average wi-nrs ≥4 at the baseline visit. * women must be of either of non-childbearing potential or childbearing potential with a negativ urine pregnancy test at baseline. * women of childbearing potential must agree to use a highly effective method of contraception. exclusion criteria: * pregnant, breast feeding, or planning to become pregnant during the trial. * any (other than vls) ongoing localized or systemic disease involving the vulvar region. * ongoing symptomatic urinary tract infection. * ongoing or prior diagnosis of any genitoanal malignancy or pre-malignancy. * any kind of ongoing cancer prior to the baseline visit. * any chronic or acute systemic medical condition that, in the opinion of the investigator, may pose a risk to the safety of the patient or may interfere with the assessment of efficacy in this trial. * known history of allergic reaction to any ingredients in mc2-25 cream or mc2-25 vehicle. * start of a new or change of existing non-biologic systemic treatment, within 21 days prior to the baseline visit. * start of a new or change of existing biologic systemic treatment, within 3 months or 5 half-lives (whichever is longest) prior to the baseline visit. * start of a new or change of existing systemic or intravaginal treatment with estrogen containing products, within 21 days prior to the baseline visit. * start of new or change of menstrual care routines within 21 days prior to the baseline visit. * use of emollients on the vulvar region within 3 days prior to the baseline visit. * use of any topical treatment on the vulvar region, within 14 days prior to the baseline visit. * use of any light therapy on the vulvar region, within 28 days prior to the baseline visit. * received a non-marketed or blinded drug within 28 days or 5 half-lives (whichever is longer) prior to the baseline visit. * if in the opinion of the investigator, the patient is unlikely to comply with the clinical trial protocol. * if previously randomized in this trial.
non-invasive positive pressure ventilation management of high altitude pulmonary edema

Conditions: High Altitude Pulmonary Edema; Non-Invasive Positive Pressure Ventilation; Hypoxia

Summary: trial of non-invasive positive pressure ventilation management of high altitude pulmonary edema

patients in the everest area will assessed for evidence of acute hape. subjects will be randomized and assigned to standard care options or treatment with non-invasive positive pressure ventilation.

Eligibility criteria:
inclusion criteria: * healthy adults (age 18-80) * travel through pheriche, nepal * diagnosis of hape by symptoms, vital signs, and lung ultrasound exclusion criteria: * history of chronic respiratory conditions (asthma, copd, ild) * concomitant pneumonia or aspiration, cardiomyopathy, congestive heart failure * kidney disease * neurologic disorder * cognitive disorder * temporary altered mental status * use of phosphodiesterase inhibitors or nifedipine prior to diagnosis of hape * age under 18 or over 80 * pregnancy
treatment of androgenic alopecia in males

Conditions: Androgenetic Alopecia; Hair Loss; Male Pattern Baldness

Summary: the purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.

this is randomized, double-blind, control device clinical study across 3 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair). the trial will involve approximately 75 male subjects who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have fitzpatrick skin types i-iv, with classifications of norwood-hamilton iia to v, have active hair loss within the last 12 months. subjects will use the device on three non-consecutive days a week as directed per device for 26 weeks treatment duration. safety analysis will be assessed based on the reports of adverse events during study.

Eligibility criteria:
inclusion criteria: * diagnosis of androgenetic alopecia * fitzpatrick skin types i-iv * norwood-hamilton iia to v * active hair loss within last 12 months exclusion criteria: * photosensitivity to laser light * malignancy in the target area

Keywords: androgenetic alopecia hair loss male pattern baldness
accuracy of coplanar template assistance for abdominal tumor puncture

Conditions: Abdominal Tumor

Summary: in recent years, template guidance has been applied and developed in the field of puncture related operations, such as template-assisted radioactive seed implantation. with the guidance of template, needle pathway of seed implantation, biopsy and fiducial marker implantation can be precisely planned actual operation, which is conducive to the accurate proceeding. templates can be divided into coplanar templates and non-coplanar templates. the digital coplanar template coordinate puncture system has been developed in china and has been applied in clinical practice. in our previous studies, coplanar template assisted ct-guided radioactive seed implantation has good clinical feasibility for percutaneous biopsy of small pulmonary nodules. however, the accuracy of coplanar template assistance for abdominal tumor puncture are lacking in prospective studies. the study aims to prospectively observe the accuracy and safety of coplanar template assisted ct-guided abdominal tumor puncture during biopsy and fiducial markers implantation.


Eligibility criteria:
inclusion criteria: 1. ages 18 to 85 2. single or multiple abdominal tumors or mass (solid, partially solid) 3. without taking drugs affecting coagulation and/or platelet aggregation are used; if used, the drug has been discontinued for a sufficient period of time (e.g. 1 week) 4. kps\>60 points, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture 5. planned biopsy and/or fiducial marker implantation with applicable puncture path 6. with informed consent. exclusion criteria: 1. poor organ function (e.g. lung function fev1\<40% and/or dlco\<50%) 2. the lesion close to blood vessels and intestine, or there is portal vein hypertension and superior vena cava compression, etc., which are expected to have high risks of puncture bleeding and intestinal injury 3. poor compliance, unable to complete coordination 4. paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.

Keywords: abdominal tumor biopsy fiducial marker coplanar template
chemotherapy for patients with locally advanced pancreatic cancer (lapc) with additional chemo-radiotherapy (crt) for patients with borderline resectable tumours

Conditions: Pancreatic Cancer

Summary: treating patients with initial local non-resectable pancreatic cancer with a combination of oxaliplatin, irinotecan \& 5-fu(folfirinox), consolidated with chemoradiotherapy in potentially resectable patients, will result in a high rate of tumor shrinkage allowing subsequent resection in patients with initial borderline resectable tumors and improved overall survival for all patients.

pancreatic cancer (pc) is the third most common gastrointestinal malignancy and one of the top ten leading causes of cancer deaths in the western world. patients with pc can be divided into three subgroups; resectable (rpc), locally advanced (lapc) and metastatic (mpc). for patients with rpc surgery offers the best chance for long term survival. however it is estimated that only 20% of patients have rpc at the time of diagnosis. for patients with lacp, invasion of local large vessels is most often the cause for non-resectability. the median survival of these patients is between 6 to 12 months and long term survival in is extremely rare. the optimal treatment of lapc is controversial. treatment strategies vary between attempts to "downstage" the tumour to rpc, or treat the patients in a palliative setting only. phase ii studies and retrospective series have evaluated various treatments regimens and strategies including chemotherapy and radiotherapy (rt) alone or in combination - chemoradiotherapy (crt). results from these trials give no clear answer regarding the best treatment strategy. however, data from several studies shows that treatment of lapc may result in shrinkage of the tumour, and thus potentially lead to a resection; also data suggests that crt after chemotherapy improves treatment efficacy. recent data from patients with mpc has show a combination of oxaliplatin, irinotecan and 5-fu (folfirinox) increases response rates from 10% to 30% and median survival to 11.1 months. the promising efficacy makes it natural to attempt this treatment in patients with lapc.

Eligibility criteria:
inclusion criteria: (major) * non-metastatic pancreatic cancer * performance status 0-1 * bilirubin \< 1.5 unl * written informed consent exclusion criteria: (major) * no prior abdominal radiotherapy * no prior chemotherapy for pancratic cancer * no severe comorbidity * patients must be able to undergo potential abdominal surgery

Keywords: pancreatic cancer chemotherapy chemoradiotherapy
potatoes, hypertension risk and endothelial function study

Conditions: Endothelial Dysfunction

Summary: white potatoes have recently been allowed back in the cash value voucher of the government food stamp program after it was stated that there were no known adverse health effects of potatoes. however, the association of potatoes with heart health, especially elevated blood pressure is not known. this study will examine the effects of potatoes on blood pressure in different populations of adults and children, and assess, in a feeding trial, the effects of an additional serving of potatoes per day on the possible mechanisms that link potatoes to high blood pressure. the investigators will also analyze the intake of potatoes in participants of the government food stamp program.

potatoes are one of the most consumed vegetables in the us and the world. in recent years, several changes have been made to government sponsored food programs with respect to potatoes, such as lifting the restriction on the number of servings of starchy vegetables (including potatoes) established by the healthy hunger-free act, and re-allowing white potatoes in the cash-value voucher for fruits and vegetables of the special supplemental nutrition program for women, infants, and children (wic), after the institute of medicine asserted that there was insufficient evidence that white potatoes had adverse health effects. however, the investigators recently reported an increased incidence of hypertension with increasing potato consumption in three large prospective us cohort studies after adjusting for sodium intake and other potential confounders. the investigators also analyzed the association of short-term potato intake from a 24-hr dietary recall with endothelial-dependent vasodilation measured by brachial artery ultrasonography in the modifiable effectors of renin system activation treatment evaluation (moderate) trial. participants who consumed one or more than one serving of boiled, baked or mashed potatoes during the previous day had a 1.7% lower endothelial-dependent vasodilation when compared with participants with no potato intake (p-value= 0.01) after adjusting for other factors. this is a relevant difference in endothelial function - by comparison, every 10 year increase in age was associated with a 1.2% lower endothelial function. therefore, the investigators plan to analyze the effect of one serving of boiled, baked or mashed potato per day on endothelial function in a crossover feeding trial of healthy adult men and women.

Eligibility criteria:
inclusion criteria: * 18-45 years of age * without known cardiovascular risk factor exclusion criteria: * history of hypertension, diabetes or cardiovascular disease

Keywords: nutrition potatoes endothelial function feeding trial
m-health for teen substance abuse and mental illness pilot

Conditions: Substance Use Disorders; Post Traumatic Stress Disorder; Adolescent Behavior; Mental Health Disorder

Summary: the study is exploring the ease and ability to integrate a mobile application in outpatient behavioral health treatment. there are two major aims to the study: 1) determine feasibility and acceptability of integrating a mobile app into behavioral health treatment for adolescents with co-occurring substance use and mental health disorders, and 2) identify initial signal of effect on engagement and/or treatment outcomes among youth who use the mobile app.

the purpose of the trial will be to demonstrate the feasibility of the proposed methodology (rate of recruitment, retention at 4-month follow-up, study procedures) as well as estimates of effect on key variables (patient engagement, patient symptoms, use of e-tools, treatment efficiency) in preparation for future studies in this line evaluating the utility of the mobile app.

Eligibility criteria:
inclusion criteria for adolescents: * aged 14-17 years * current substance use disorder (sud) * co-occurring mental health disorder * treatment-seeking * english-speaking (only english documents will be used throughout the course of this research study) exclusion criteria for adolescents: * younger than 14 or older than 17 * endorsement of active suicidal or homicidal ideation * active mania or psychosis * significant cognitive disability, developmental delays, or pervasive developmental disability * no history of outpatient psychotherapy. inclusion criteria for providers * clinician delivering outpatient dual diagnosis treatment (i.e., for co-occurring suds and mental health disorders) * therapist with at least a master's degree in a counseling related field
greater occipital nerve (gon) block effectivity in the treatment of chronic migraine: 6 months follow up

Conditions: Migraine Disorders

Summary: this study evaluates effectiveness of greater occipital nerve blocks with bupivacaine compared to placebo in chronic migraine patients.

the greater occipital nerve (gon), which derives most of its fibers from the c2 dorsal root, is the primary sensory nerve of the occipital region. the response to gon blockade was not simply dependent on the direct local anesthetic effect of the injection . the mechanism of action might have been via changes in brain nociceptive pathways. another possible explanation for these findings is, therefore, that gon injections initiated diffuse noxious inhibitory controls, independent of anesthetic effect . neurophysiological and clinical data suggest there is a functional connection between the sensory occipital segments and the trigeminal nociceptive system in humans.

Eligibility criteria:
inclusion criteria: * chronic migraine headache according to international headache society classification criteria * patients who are not using any prophylacting agent exclusion criteria: * patients given similar treatments before * pregnant women * hereditary diseases causing bleeding * patients who have intracranial tumor or operation in posterior fossa * allergic reactions to local anesthetics.
non-invasive test to detect intra-amniotic infection in women with preterm labor and intact amniotic membranes

Conditions: Intra-amniotic Infection

Summary: the purpose of this study is to collect clinical specimens and corresponding clinical data to develop a non-invasive test for detection of intra-amniotic infection and prediction of preterm birth in women and intact amniotic membranes. the specimens collected will be used to develop a specific biomarker panel and algorithm using immunoassays for optimal detection of intra-amniotic infection in women with preterm labor and intact amniotic membranes.

intra-amniotic infection (iai) is an acute bacterial infection of the amniotic fluid and intrauterine contents during pregnancy and occurs in 4% to 10% of all deliveries (newton, er., 1993. newton, er, et al., 1989. soper, de, et al., 1989). iai is an important cause of maternal and neonatal morbidity. identifying and appropriately treating women with iai is, therefore, a major obstetrical challenge. intrauterine infection may occur early in pregnancy and remain undetected for a prolonged period, thus exposing the fetus to the effects of infection/inflammation for a considerable period. ideally, an early diagnosis of iai is important to allow timely treatment and intervention. unfortunately, the early diagnosis is difficult because the clinical signs and symptoms of iai may occur late in the course of the infection and are neither sensitive nor specific. therefore, to avoid a delay in diagnosis a high degree of suspicion and the appropriate use of adjunctive laboratory tests are warranted.

Eligibility criteria:
inclusion criteria: * subject is greater than or equal to 18 years of age * subject has singleton gestation * subject has fetus with gestational age greater than or equal to 22 0/7 weeks and less than or equal to 36 6/7 weeks * subject has documented intact amniotic membranes * subject's care provider plans to or has performed an amniocentesis procedure * subject has had evidence of spontaneous preterm labor as evidenced by documented regular uterine contractions (greater than or equal to four per hour, or if less than 26 weeks gestation, cramping or backache) and one or more of the following: 1. progressive cervical change with cervical dilation of greater than or equal to 2 cm 2. effacement of greater than or equal to 50% 3. cervical length of less than or equal to 30 mm via transvaginal ultrasound 4. positive fetal fibronectin test exclusion criteria: * subject has documented ruptured amniotic membranes * subject has fetus with major fetal anomaly or chromosomal aneuploidy * subject has medical indication for preterm birth (e.g. pre-eclampsia) * subject is unable to provide written informed consent

Keywords: preterm labor preterm birth intra-amniotic infection pregnancy women